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Ezetimibe-Simvastatin Evaluation Study (ZEUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03947866
Recruitment Status : Not yet recruiting
First Posted : May 13, 2019
Last Update Posted : July 3, 2019
Information provided by (Responsible Party):
Elpen Pharmaceutical Co. Inc.

Brief Summary:
The study purpose is to assess the efficacy of the fixed combination of ezetimibe-simvastatin in patients with hypercholesterolemia not responding to statin monotherapy in achieving the blood plasma LDL-C target as defined by the ESC / EAS Guideline, of 2016.

Condition or disease
Hypercholesterolemia Hyperlipidemias Statin Monotherapy Response

Detailed Description:

The additional study objectives are:

  1. To evaluate the efficacy of a fixed combination of ezetimibe-simvastatin in patients with hypercholesterolemia to improve the lipid profile (HDL-C ↑, T-CHOL, Triglycerides ↓).
  2. Evaluation of the response of patients with hypercholesterolemia who received a fixed combination of ezetimibe-simvastatin to achieve a target according to the category of total cardiovascular risk to which they belong.
  3. To evaluate the efficacy of a stable combination of ezetimibe and simvastatin in patients with hypercholesterolemia in improving non-HDL-cholesterol (non-HDL-C) levels.
  4. Safety assessment through the recording of Adverse Events during the study.

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Study Type : Observational
Estimated Enrollment : 2000 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Non-interventional, Multicenter, Clinical Observational Study to Evaluate the Efficacy of a Fixed Combination of Ezetimibe and Simvastatin in Hypercholesterolemic Patients Not Responding to Statin Monotherapy.
Estimated Study Start Date : October 1, 2019
Estimated Primary Completion Date : January 31, 2020
Estimated Study Completion Date : January 31, 2020

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. LDL-C [ Time Frame: 3 months ]
    Levels of LDL-C

Secondary Outcome Measures :
  1. Lipidemic profile [ Time Frame: 3 months ]
    HDL-C↑ T-CHOL, Triglycerides measurements

  2. Cardiovascular risk factor [ Time Frame: 3 months ]
    Response of patients vs target of total cardiovascular risk to which they belong.

  3. Adverse Events [ Time Frame: 3 months ]
    Number of Adverse Events during the study.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with hyperlcholesterolaemia - not responders to statin monotherapy.

Inclusion Criteria:

  • Patients diagnosed with primary (heterozygous familial and non-familial) hypercholesterolemia, homozygous familial hypercholesterolemia or mixed hyperlipidemia.
  • Patients not properly responded with a statin only.
  • Patients who have not achieved LDL-C with previous treatment.
  • Adult patients who will sign their consent form to participate in the study.

Exclusion Criteria:

  • Patients who have not fully understood the study procedures and have not signed the consent form.
  • Hypersensitivity to the active substances or to any of the excipients of study drug.
  • Pregnancy and breastfeeding.
  • Active liver disease or unexplained persistent increases in serum transaminases.
  • Concomitant administration of potent inhibitors of the CYP3A4 system (agents that increase the AUC approximately 5 times or more) (eg, itraconazole, ketoconazole, posaconazole, voriconazole, erythromycin, clarithromycin, telithromycin, HIV protease inhibitors (eg nelfinavir ), boceprevir, telaprevir, nefazodone and combesistate containing medicines.
  • Concomitant administration of gemfibrozil, cyclosporine or danazol.
  • Patients with homozygous familial hypercholesterolaemia (HoFH), concurrent administration of lopithipid with doses of study drug> 10 mg / 40 mg.

M. Elisaf, Chr. Pitsavos, Ev. Liberopoulos, K. Tziomalos, V. Athyros. Updated guidelines of the Hellenic Society of Atherosclerosis for the diagnosis and treatment of dyslipidemia. Hellenic Journal of Atherosclerosis (2014) 5: 151-163
D. B. Panagiotakos. Cardiovascular Disease Risk Models. Hellenic Journal of Atherosclerosis (2013) 4: 151-157
M.Elisaf, A.Kei, T.Alexandrides, E. Liberopoulos. The impact of improve-it study. Hellenic Journal of Atherosclerosis 6: 153-154
A. Kei, M.Elisaf. Current role of fibrates in the treatment of dyslipidemia. Hellenic Journal of Atherosclerosis 5(2): 106-11

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Responsible Party: Elpen Pharmaceutical Co. Inc. Identifier: NCT03947866     History of Changes
Other Study ID Numbers: 2019-SMEZ-EL-103
First Posted: May 13, 2019    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lipid Metabolism Disorders
Metabolic Diseases
Anticholesteremic Agents
Hypolipidemic Agents
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors